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Hematologic Diseases clinical trials

View clinical trials related to Hematologic Diseases.

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NCT ID: NCT04150393 Completed - Chemotherapy Effect Clinical Trials

Safety and Tolerability Evaluation of MaaT033

CIMON
Start date: October 20, 2020
Phase: Phase 1
Study type: Interventional

Richness and diversity of gut microbiota are increasingly found to be associated with cancer outcomes. Moreover, an adequately responsive immune system seems to rely on the existence of a functioning gut ecosystem that includes the microbiota and its natural environment. Cancer by itself, but also cancer treatments - in particular chemotherapy - induce gut dysbiosis, impair the constant reparation mechanisms of the gut epithelium, disrupt immune homeostasis, and stunt immune responsiveness. The objective of MaaT033 is to (1) prevent the decay of the gut ecosystem (dysbiosis) to preserve immune homeostasis, (2) restore and optimize the gut ecosystem to full functionality including its role in repairing the gut epithelium and healthy gut barrier, and (3) maintain a restored gut ecosystem and fully functional immune homeostasis. Restoring the full gut ecosystem and its associated microbiota could become an important therapeutic option to improve clinical outcomes and control adverse events of conventional approaches, including immunotherapy in cancer patients. As a first step, MaaT033 capsules containing lyophilized, pooled, full-ecosystem microbiota in its natural environment are to be tested for their safety and tolerability in hematological malignant patients, who are exposed to intensive rounds of chemotherapy and antibiotics.

NCT ID: NCT04039100 Completed - Multiple Myeloma Clinical Trials

Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Background: Family caregivers are of great importance to patients undergoing treatment for cancer, but at the same time, caregivers themselves are in great risk of distress and high symptom burden which affects their quality of life and ability to support the patients. Within hematology the context of treatment from hospital to home has changed in the past years placing more responsibilities on caregivers. Finding new ways to support caregivers within the health care context is important. Psychosocial interventions can enhance emotional well-being, and peer to peer support model has been found to be effective for patients coping with cancer. There is a lack of knowledge and evidence of the feasibility and effects of a peer-to-peer support in caregivers within hematology. Aims: The study aim to examine the feasibility and safety of Family Caregiver Ambassador Support in caregivers of newly diagnosed patients with hematological disease, and to examine if it has an effects on symptoms and psychological wellbeing in both family caregivers and ambassadors. It is hypothesized that the family caregiver peer to peer support model will reduce symptoms of burden, reduce concerns and improve emotional and social well-being in family caregivers. Design and methods: The study is a one arm feasibility intervention trial with family caregivers (n=30) and family caregiver ambassadors (N=20). Family Caregivers will be recruited at the Department of Hematology, Rigshospitalet. Family Caregivers will be partnered with a family caregiver ambassador. The intervention will be carried out in a 12-week period and consist of telephone and/or e-mail contact and face to face meetings with one follow-up at three months. Both caregiver and ambassador data will be collected at baseline, post intervention and follow-up 3 months. Implication: The study has the potential to be a new model of care incorporated in the clinical setting to strengthen the support system for caregivers and may likely be tailored to other cancer groups and caregivers.

NCT ID: NCT03895918 Completed - Malignant Neoplasm Clinical Trials

Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

Start date: January 3, 2019
Phase: N/A
Study type: Interventional

This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.

NCT ID: NCT03886909 Completed - Physical Activity Clinical Trials

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

IMPROVE-BMT
Start date: June 28, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether patients are able to participate in a prehabilitation program (prior to the beginning of treatment) which includes: (1) a home-based exercise program or (2) just a prehabilitation education session.

NCT ID: NCT03876301 Completed - Hemophilia A Clinical Trials

Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants

Start date: January 21, 2019
Phase:
Study type: Observational

The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of care. The data collected from this study may assist in providing baseline information for comparison to the Spark's investigational hemophilia A gene therapy in future Phase 3 studies.

NCT ID: NCT03875352 Completed - Surgery Clinical Trials

The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Assessing the impact of the nursing technique applied at the insertion site of the central venous catheter using hydrophilic methacrylate gel (HMG) and 2% Chlorhexidine (CHG) upon the incidence of inflammatory complications when treating the surrounding of the central venous catheter.

NCT ID: NCT03855631 Completed - Kabuki Syndrome 1 Clinical Trials

Exploiting Epigenome Editing in Kabuki Syndrome: a New Route Towards Gene Therapy for Rare Genetic Disorders

Epi-KAB
Start date: September 28, 2020
Phase:
Study type: Observational

Starting from isolating primary cells from affected patients, an in vitro disease model system for KS will be developed. Using alternative strategies to obtain patient-derived mesenchymal stem cells, an integrative approach will be adopted for defining both the transcriptional and epigenetic regulatory networks perturbed upon the loss of function of KMT2D. Combining the self-renewal potential of mesenchymal stem cells (MSCs) with CRISPR/Cas9 technology, an epigenome editing approach as therapeutic strategy to rescue the activity of MLL4 will be developed. A step forward is expected towards the understanding of those the molecular mechanisms governing the aetiology of Kabuki Syndrome (KS) and that the proposed in vitro disease model will provide to the scientific community an experimental system to study the KS. Importantly, the aim is to define the molecular bases of KS and to develop a therapeutic strategy that could ameliorate some of the abnormalities associated with KS.

NCT ID: NCT03815175 Completed - Clinical trials for Coronary Artery Disease

XIENCE 28 USA Study

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.

NCT ID: NCT03778606 Completed - Clinical trials for Hematologic Diseases

Oligosaccharide for Cdiff(+) Heme-onc Patients

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Clostridium difficile causes ~453,000 infections and ~29,300 deaths per year in the US, making it the most common hospital acquired infection in the country. C. difficile is an anaerobic bacterium that has the capacity to inhabit the colon of humans and other mammals. Initially thought to be a commensal, it was later found to be associated with antibiotic induced enterocolitis. Since then, it has gradually become one of the most important healthcare associated pathogens. C. difficile infection (CDI) causes colitis, which is inflammation of the colonic mucosa with a spectrum of severity from mild to more protracted diarrhea, abdominal pain, fever, toxic megacolon, sepsis, and in some instances death. Mortality occurs despite the existence of three antibiotic options. CDI is also associated with higher hospital readmission rates, and associated healthcare costs in the US are estimated at 4.8 billion dollars annually. Due to the significance of C. difficile in healthcare, hospital level C. difficile rates are publically reported and closely scrutinized by the Centers for Medicare and Medicaid. Standard infection control bundles are proving to be insufficient for controlling the national C. difficile problem. Better understanding of the biological steps preceding clinical infection and reversal of the underlying gut dysbiosis will allow us to curtail our C. difficile epidemic. The present study aims to manipulate the gut microbiota to halt the biological progression of C. difficile. CDI is a serious problem in hematology-oncology patients. The incidence of CDI in the hematology-oncology population is much higher than in other populations and hematology-oncology inpatient units frequently have the highest incidence of CDI cases within an institution. Additionally, hematology-oncology patients have high rates of C. difficile colonization upon hospitalization and more than 50% of patients detected with C. difficile colonization before bone marrow transplantation end up diagnosed with hospital associated CDI. This finding is not trivial as CDI treatment with oral vancomycin causes major and prolonged perturbations of their intestinal microbiota, which has been associated with higher mortality. In addition to the usual complications of CDI, a higher incidence of graft-versus-host-disease has been described in patients with CDI.

NCT ID: NCT03734588 Completed - Clinical trials for Hematologic Diseases

Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors

Start date: January 30, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.